Associate Director, Pre-Commercial Quality Assurance

Associate Director, Pre-Commercial Quality Assurance

Location:

Greenville, NC

Catalent is a global, high‑growth, public company that partners with the pharmaceutical industry to develop and manufacture new treatments. Our Greenville, NC facility specializes in end‑to‑end turnkey solutions for oral solid dosage forms, including formulation development, analytical services, commercial manufacturing, and packaging. The facility has received over $100M in recent investments and offers fit‑for‑scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.

Catalent is committed to a Patient‑First culture with a focus on quality and compliance and the safety of every patient, consumer, and employee.

• Act as Pre‑Commercial QA SME during FDA, non‑domestic, and client audits and lead the preparation of responses to all audit observations, particularly those related to Pre‑Commercial Quality Assurance findings.
• Lead the site cross‑functional team effort to drive all pre‑commercial CAPA commitments for audit responses and eQMS events to timely completion and effectiveness evaluation.
• Lead the team‑based approach for review and verification of drug product quality in manufacturing, packaging, and testing records to ensure only compliant product is released and non‑conforming materials are investigated and dispositioned appropriately.
• Lead the development of a culture and supporting systems to drive open communication, participation, and intra/inter‑departmental idea‑sharing; advance and model company values and leadership commitments; ensure the highest levels of quality, compliance, and integrity are adhered to in all interactions.
• Direct operations within Pre‑Commercial Quality Assurance while maintaining a continuous improvement philosophy focused on improved compliance, right‑first‑time performance, and process efficiency, creating an environment of open communication and information‑sharing within and between teams within Quality Assurance and throughout the commercial organization.
• Establish and maintain active KPIs for the functional measures within Pre‑Commercial Quality Assurance, including periodic reporting for the KPIs; monitor and trend key quality data for internal and external commercial supplies to support the S&OP scorecard program.

• PhD with at least 7 years of professional experience in QA/QC pharmaceutical manufacturing.
• Master’s degree with at least 9 years of professional experience in QA/QC pharmaceutical manufacturing.
• Bachelor’s degree with 10 years of professional experience in QA/QC pharmaceutical manufacturing.
• At least 4 years of leadership/management experience with demonstrated ability to set vision and direction for a team, including setting expectations and motivating for results to achieve corporate, site, and departmental objectives.
• Extensive technical skills in solid‑dose manufacturing and/or packaging; experience in contract manufacturing preferred.
• Experience leading audit preparations.
• Experience with electronic quality management systems such as deviation management, analytical investigations (OOS), CAPA, and change control.

• Spearhead exciting and innovative projects.
• Fast‑paced, dynamic environment.
• High visibility to members at all levels of the organization.
• 152 hours of PTO + 8 paid holidays.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent produces more than 70 billion doses per year; each one has a real impact.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, please send your request by email, including the job number, title, and location to Disabili This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.